Leaflet: information for the user

Dosil 100 mg hard capsules

Doxiciclina

Read this leaflet carefully before you start taking the medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What is Dosil and what it is used for

2. What you need to know before starting to take Dosil

3. How to take Dosil

4. Possible side effects

5. Storage of Dosil

6. Contents of the pack and additional information

Dosilcontains doxiciclina, an antibiotic that belongs to a group called tetraciclinas.

Antibiotics are used to treat bacterial infections and do not work for viral infections.

Do not store or use this medication. If you have leftover antibiotic after completing treatment, return it to the pharmacy for proper disposal. Do not dispose of medications through the drain or in the trash.

Dosil is indicated for:

• the treatment of the following infections:

• Atypical pneumonia.
• Psittacosis (a disease transmitted by certain birds that presents as pneumonia accompanied by fever and cough).
• Urethritis (inflammation of the urethra), cervicitis (inflammation of the cervix), proctitis (inflammation of the rectum), lymphogranuloma venereum (an infection characterized by ulcers on the genitals followed by lymph node inflammation), granuloma inguinale (purulent ulceration of the genitals), pelvic inflammatory disease, syphilis in patients allergic to penicillin, acute epididymo-orchitis (inflammation of the testicles, purulent, and primarily affecting newborns).
• Eye infections such as trachoma, inclusion conjunctivitis.
• Typhus and other infections caused by microorganisms called rickettsias.
• Brucellosis (Malta fever).
• Cholera (an infectious disease that presents with severe diarrhea, dehydration, and vomiting).
• Early stages of Lyme disease (transmitted by ticks).
• Recurring fevers transmitted by lice and ticks.
• Malaria (an infectious disease presenting with fever, chills, and sweating, caused by microorganisms that parasitize red blood cells).
• Severe vulgar acne.

• Alternative treatment for: carbuncle (an infectious disease affecting the skin, intestines, or lungs), tularemia (a rodent disease similar to the plague), listeriosis (a severe infectious disease that can affect the fetus during pregnancy, the newborn, and the adult), bartonellosis (an infectious disease presenting with severe anemia and fever), and actinomycosis (an infectious disease causing lymph node inflammation in the mouth and other internal complications).

• Prevention of malaria (transmitted through mosquito bites) and prevention of anthrax after exposure to bacteria causing this disease.

Do not take Dosil

-If you are allergic to doxycycline, any other tetracycline, or any of the other components of this medication (listed in section 6).

-If you are using it together with methoxyflurane (a medication used for anesthesia), as it can cause severe kidney toxicity with fatal outcome.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Dosil:

-If during treatment with Dosil you notice abnormal headaches accompanied by dizziness, blurred vision, ringing in the ears, nausea, or vomiting, consult your doctor, as they may be symptoms of benign intracranial hypertension (a process affecting the brain due to an increase in pressure within the skull). In young children, it may cause fontanelle bulging (unossified space of the skull in young children). These alterations disappear when the treatment is interrupted,

-If you are taking a medication called isotretinoin, as taken together with Dosil it may cause benign intracranial hypertension,

• If you experience intense and prolonged diarrhea while on treatment with doxycycline, you may have a type of antibiotic-associated colitis called pseudomembranous colitis, which can be severe. In these cases, you should consult your doctor, who will decide whether to discontinue doxycycline administration and initiate an appropriate treatment,
• If you ingest this medication lying down or without sufficient water or milk, it may cause esophageal inflammation and ulcers, so it is essential to follow the administration instructions exactly (see section 3),
• If you have liver disease, consult your doctor. In prolonged treatments, your doctor may need to perform periodic analytical controls,
• It is recommended to use sunscreen with a total sun protection factor and avoid exposure to the sun or ultraviolet radiation, as it may cause skin reddening. If this occurs, you should consult your doctor,
• The use of antibiotics may increase the risk of developing infections caused by microorganisms that are not sensitive to treatment, including fungi, so your doctor will monitor for any possible signs of infection,
• If you need to undergo a urine analysis, inform the healthcare staff that you are on treatment with Dosil, as it may interfere with the results,

Children

-Dosilshould not be used in children in the teething period (last half of pregnancy, infants, and children under 8 years old) because it may cause permanent tooth discoloration, as well as delayed bone development.

Use in children and adolescents

-In children under 8 years old, the use of Dosil is not recommended.

• In children over 8 years old and up to 45 kg of weight, there is another presentation more suitable for dose adjustment.

-In children over 8 years old and over 45 kg of weight, it is recommended to use the same dose as in adults, see section 3.

Taking Dosil with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Certain medications may interact with Dosil. In these cases, it may be necessary to change the dose or discontinue treatment with one of the medications. It is especially important to inform your doctor if you are using any of the following medications:

• Penicillin, as Dosil may interfere with its effect.
• Oral contraceptives, as Dosil may reduce their effectiveness.
• Anticoagulants (such as warfarin), as Dosil may alter their effect.
• Antacids (medications used to calm stomach acidity) and other medications containing aluminum, calcium, or magnesium, and medications containing iron or bismuth salts, as they may reduce the effect of Dosil.
• Antiepileptics and barbiturates (medications for severe insomnia and seizures), as they may reduce the effect of Dosil.
• Methoxyflurane (a medication used for anesthesia), as when used together with antibiotics in the tetracycline group, such as Dosil, it may cause severe kidney toxicity.

Taking Dosil with food, drinks, and alcohol

• You should avoid consuming alcohol during treatment with Dosil, as alcohol reduces the effect of doxycycline.
• It is essential to take Dosil during a meal, accompanied by a large glass of water or milk, to avoid esophageal irritation (see section 3).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

The use of Dosil during pregnancy is not recommended, as it may cause bone and tooth development disorders in the child. Your doctor will decide whether to use Dosil in these cases.

It is essential to use contraceptive methods to avoid pregnancy during treatment with Dosil. Oral contraceptives (hormonal) may not be effective, as taking Dosil reduces their contraceptive effect, and it is recommended to use barrier methods.

Breastfeeding

The use of Dosil during breastfeeding is not recommended, as it may cause bone and tooth development disorders in the infant.

Driving and operating machinery

There is no evidence that Dosil affects the ability to drive or operate machinery.

This medication contains lactose and wheat starch

This medication contains lactose. If your doctor has indicated that you have a certain sugar intolerance, consult with them before taking this medication.

This medication contains wheat starch, equivalent to 100 ppm of gluten, which should be taken into account by patients with celiac disease.

Patients with wheat allergy (other than celiac disease) should not take this medication.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Remember to take your medication. It is essential to take the capsules regularly at the same time of day.

Your doctor will indicate the duration of treatment with this medication. Do not discontinue treatment until your doctor tells you to, even if you have started to improve.

The dose will be established by the doctor based on your individual characteristics and the type of infection. As a general rule,the usual dose and frequency of administration is as follows:

Adults:

- The usual dose is 200 mg of doxycycline (2 capsules of 100 mg) on the first day of treatment, administered in a single dose or divided into two doses, and then continue with 100 mg of doxycycline (1 capsule) to complete the treatment, administered in a single dose or divided into two doses.

- For the treatment of more severe infections (particularly chronic urinary tract infections), 200 mg should be administered daily throughout the treatment period. In general, treatment should continue for at least 24 to 48 hours after the disappearance of symptoms and fever.

Specific dosing guidelines for adults:

(1)Due to the potential severity of the infection, a rapid-acting antimalarial agent such as quinine should always be administered in combination with doxycycline. Quinine dosing recommendations vary by geographic area.

There are different doses available for various dosing regimens.

Patients with liver dysfunction

Doxycycline should be administered with caution in patients with liver dysfunction.

Patients with renal insufficiency

Doxycycline does not require dose adjustment in patients with renal dysfunction.

Patients of advanced age

No dose adjustment is necessary.

Use in children and adolescents

In children under 8 years, the use of Dosil is not recommended.

In children over 8 years and up to 45 kg, there is another presentation more suitable for dose adjustment.

In children over 8 years and over 45 kg, the same dose as in adults is recommended.

Administration form

Oral administration.

If you take more Dosil than you should

Information for healthcare professionals: In case of overdose, discontinue administration, initiate symptomatic treatment, and supportive measures.

Peritoneal dialysis does not alter plasma elimination half-life and therefore would not be beneficial in treating overdose.

In case of overdose or accidental ingestion,consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Dosil

If you forget to take a dose, take the next one at the usual time. Do not take a double dose to compensate for the missed doses. It is essential to take the medication regularly at the same time of day.

Like all medications, this medication may cause side effects, although not everyone will experience them.

The following side effects have been observed in patients who have taken tetracyclines, including doxycycline, listed in order of their frequency of occurrence:

Frequent side effects (may affect up to 1 in 10 people):

Allergic reactions (including skin and mucous membrane edema (angioedema), exacerbation of lupus erythematosus, pericarditis, hypersensitivity, serum disease, Henoch-Schonlein purpura, hypotension, shortness of breath (dyspnea), tachycardia (rapid pulse), peripheral edema, and red, elevated, itchy skin lesions (urticaria), headache, nausea, vomiting, exaggerated skin reaction to sunlight or ultraviolet radiation, skin rash (including erythematous and maculopapular types).

Rare side effects (may affect up to 1 in 100 people):

Digestive alterations (gastritis).

Infrequent side effects (may affect up to 1 in 1,000 people):

Severe destruction of red blood cells (hemolytic anemia), decreased platelet count (thrombocytopenia), alteration in white blood cell count: decreased neutrophil count (neutropenia) or increased eosinophil count (eosinophilia), drug-induced rash with eosinophilia or systemic symptoms, brown-black microscopical discoloration of the thyroid gland, decreased appetite, increased intracranial pressure (benign intracranial hypertension) in adults, fontanelle bulging (unossified skull space in young children) in children, tinnitus, facial redness (rubefaction), altered stool volume or consistency (diarrhea, pseudomembranous colitis), esophageal ulcers, esophagitis, enteritis, anogenital inflammatory lesions, dysphagia, abdominal pain, glossitis, liver dysfunction, hepatitis, and liver damage, toxic epidermal necrolysis, severe skin and mucous membrane inflammation (Stevens-Johnson syndrome), multiform erythema, extensive skin peeling (dermatitis exfoliativa), nail loss (photoonycholysis), arthralgia, and myalgia, elevated blood urea.

Side effects of unknown frequency (cannot be estimated from available data):

Jarisch-Herxheimer reaction, which is characterized by fever, chills, headache, muscle pain, and skin rash, and usually resolves spontaneously. It occurs shortly after the start of doxycycline treatment for spirochetal infections, such as Lyme disease.

Like all tetracyclines, doxycycline may cause permanent discoloration of teeth (from grayish-brown to yellowish) and alteration of bone growth.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

Store in the original packaging to protect it from moisture.Do not store at a temperature above 30°C.

Do not usethis medicationafter the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

Composition of Dosil

- The active ingredient is doxycycline. Each capsule contains 100 mg of doxycycline (as hyclate).

- The other components are:

Content of the capsule:calcium hydrogen phosphate, magnesium trisilicate, wheat starch, lactose monohydrate, and magnesium stearate.

Appearance of the product and content of the packaging

Dosil is presented in the form of hard green capsules.

Aluminum and PVC blister.

Each package contains 14 or 500 hard capsules.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Laboratorios Llorens, S.L.

Ciudad de Balaguer, 7-11

08022 Barcelona

Responsible for manufacturing

Laboratorios Llorens S.L.

C/ Llacuna, 19-21

08005 Barcelona

Last review date of this leaflet: 04/2024

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/